{"id":31225,"date":"2012-08-23T13:41:14","date_gmt":"2012-08-23T17:41:14","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=interventional&#038;p=31225"},"modified":"2012-08-23T13:42:41","modified_gmt":"2012-08-23T17:42:41","slug":"new-des-get-comfortable-with-ami","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/08\/23\/new-des-get-comfortable-with-ami\/","title":{"rendered":"New DES Get COMFORTABLE with AMI"},"content":{"rendered":"<p>The use of drug-eluting stents (DES) in patients with acute myocardial infarction (AMI) has recently generated concern. In\u00a0two meta-analyses (<a href=\"http:\/\/archinte.jamanetwork.com\/article.aspx?articleid=1135428\">De Luca et al <\/a>and <a href=\"http:\/\/eurheartj.oxfordjournals.org\/content\/33\/8\/977.long\">Kaleson et al<\/a>)\u00a0, the use of early-generation DES resulted in a lower risk of repeat revascularization compared with\u00a0bare-metal stents (BMS) in patients with AMI, but the DES\u00a0group had a 2-fold increased risk\u00a0for very late stent thrombosis (after the first year). These findings were attributed, at least in part, to the permanent polymer coating on the DES that has \u201c<a href=\"http:\/\/jama.jamanetwork.com\/article.aspx?articleid=1352094\">an early protective effect against stent thrombosis and a late proinflammatory and prothrombotic effect<\/a>,\u201d which may be responsible for the delayed arterial healing, incomplete endothelialization, uncovered stent struts, inflammation, and persistent fibrin deposition that was observed.<\/p>\n<p>Second-generation DES with biodegradable polymers provide controlled drug release with subsequent degradation of the polymer and a lower risk for stent thrombosis than first generation DES.<\/p>\n<p>In the prospective, randomized <a href=\"http:\/\/jama.jamanetwork.com\/article.aspx?articleid=1352112\">COMFORTABLE AMI (<em>Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) <\/em>trial<\/a>, 1161 patients with STEMI were randomized to receive biolimus (an equipotent sirolimus analogue)-eluting stents or BMS, after which they were followed-up for 12 months. Compared with BMS, the use of biolimus-eluting stents with a biodegradable polymer resulted in a lower rate of major adverse cardiac events (4.4% absolute reduction).<\/p>\n<p><strong><em>COMFORTABLE AMI Trial Results<\/em><\/strong><\/p>\n<table border=\"1\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td width=\"399\">\n<p align=\"center\">Endpoint<\/p>\n<\/td>\n<td valign=\"top\" width=\"120\">\n<p align=\"center\">Bare metal stent<br \/>\n(n=582)<\/p>\n<\/td>\n<td valign=\"top\" width=\"128\">\n<p align=\"center\">Biolimus-eluting stent (n=575)<\/p>\n<\/td>\n<td valign=\"top\" width=\"152\">\n<p align=\"center\">Hazard ratio (HR),<br \/>\n<em>P<\/em> value<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"399\">Composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization<\/td>\n<td width=\"120\">\n<p align=\"center\">8.7%<\/p>\n<\/td>\n<td width=\"128\">\n<p align=\"center\">4.3%<\/p>\n<\/td>\n<td width=\"152\">\n<p align=\"center\">HR, 0.49;<br \/>\n<em>P<\/em> =0.004<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"399\">Target vessel\u2013related reinfarction<\/td>\n<td width=\"120\">\n<p align=\"center\">2.7%<\/p>\n<\/td>\n<td width=\"128\">\n<p align=\"center\">0.5%<\/p>\n<\/td>\n<td width=\"152\">\n<p align=\"center\">HR, 0.20;<br \/>\n<em>P<\/em>=0.01<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"399\">Ischemia-driven target-lesion revascularization<\/td>\n<td width=\"120\">\n<p align=\"center\">5.7%<\/p>\n<\/td>\n<td width=\"128\">\n<p align=\"center\">1.6%<\/p>\n<\/td>\n<td width=\"152\">\n<p align=\"center\">HR, 0.28;<br \/>\n<em>P<\/em>&lt;0.001<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em>\u00a0(Adapted from R\u00e4ber L et al. JAMA 2012 Aug 22\/29; 308:77.)<\/em><\/p>\n<p>The findings for the composite endpoint were consistent across stratified analyses for diabetes mellitus, renal failure, thrombus aspiration, small-vessel disease, and lesion length.<\/p>\n<p>Unfortunately, the biolimus-eluting stent is currently not approved by the U.S. FDA.<\/p>\n<p><strong><em>Do concerns of late stent thrombosis influence your decision to use DES in the setting of AMI?<\/em><\/strong><\/p>\n<p><strong><em>Given <a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/interventional\/des-in-patients-at-low-risk-for-tvr-is-the-benefit-worth-the-cost-part-i\/\">concerns\u00a0about overuse of DES<\/a>, should we be using\u00a0DES less\u00a0\u2014 or more\u00a0\u2014\u00a0frequently in AMI patients?<\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The use of drug-eluting stents (DES) in patients with acute myocardial infarction (AMI) has recently generated concern. In\u00a0two meta-analyses (De Luca et al and Kaleson et al)\u00a0, the use of early-generation DES resulted in a lower risk of repeat revascularization compared with\u00a0bare-metal stents (BMS) in patients with AMI, but the DES\u00a0group had a 2-fold increased [&hellip;]<\/p>\n","protected":false},"author":214,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[1108,945,1221,1418,821,1419,302,437],"class_list":["post-31225","post","type-post","status-publish","format-standard","hentry","category-interventional-cardiology","tag-acute-myocardial-infarction","tag-bare-metal-stents","tag-biodegradable-stents","tag-comfortable-ami","tag-drug-eluting-stents","tag-late-stent-thrombosis","tag-primary-pci","tag-stents"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31225","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/214"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=31225"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31225\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=31225"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=31225"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=31225"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}